Study of Antitumor T Cell Immune Responses in Patients With Bladder Cancer

Centre Hospitalier Universitaire de Besancon0 sites33 target enrollmentApril 2, 2024

ConditionsBladder Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bladder Cancer
Sponsor: Centre Hospitalier Universitaire de Besancon
Enrollment: 33
Primary Endpoint: Tumor antigen specific T-cell responses
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor.

Registry

clinicaltrials.gov

Start Date

April 2, 2024

End Date

April 2, 2026

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Besancon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients undergoing transurethral resection of the bladder (TURBT) for a tumor detected by cystoscopy with a histological diagnosis of a non-infiltrating or muscle-infiltrating tumor
•For muscle-invasive tumors: localized tumors (T2-T3N0M0) or locally advanced (T4N0M0)
•Written informed consent

Exclusion Criteria

•History of TURBT for a bladder tumor whatever the stage
•Stages N1-3 or M1 on initial assessment
•Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
•History of cancer in the last 3 years other than basal cell carcinoma or non-invasive cervical cancer
•HIV, hepatitis C or B infection
•Patients with any medical or psychiatric condition or disease,
•Patients under guardianship, curatorship or under the protection of justice.

Outcomes

Primary Outcomes

Tumor antigen specific T-cell responses

Time Frame: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)

Increase in the post-treatment sample of at least 30% in the level of anti-TERT Th1 lymphocytes in the blood measured by the ELISpot IFN-γ method, compared to the measurement at baseline.

Secondary Outcomes

Monitoring of immune cell death parameters in the blood(15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C))
Transcriptomic analysis(At baseline)
Monitoring of T cells in the blood(15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C))
Local progression-free survival(date of first local progression of the disease (within 2 year after the initiation of the treatment))
Monitoring of immune suppressive cells in the blood(15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C))
Progression-free survival(date of first progression of the disease (within 2 year after the initiation of the treatment))
Overall survival(Date of death from any cause (within 2 years after the initiation of the treatment))